Abstract

Objectives:To perform stability indicating analytical method development and validation of Lafutidine in tablet dosage form by reverse phase HPLC method. Materials and Methods: The method was developed employing isocratic RP- HPLC and validated for assay of Lafutidine in tablet dosage form. The method employs the use of a UV detector. Results:The developed assay method was found to be accurate, precise, reproducible and robust and was linear over a concentration range of 20 - 100μg/mL.Conclusion: The developed method was tried for its applicability in stability indicating assay. Various stress studies were carried out and the method was able to estimate Lafutidine, but was unable to estimate the degradation products of acid and alkaline stress conditions. The method was able to quantify degradation products in oxidative stress conditions